二甲双胍片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118037480034801998012880196801860.16
218051180406804580.10
单位质量响应值RSD%判断
80186.0080458.000.24数据可信
供试品溶液-25041001批-二甲双胍-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1158694-15869412.70812.304.2412.7112.304.25
2154916-15491612.40512.41
3143727-14372711.50911.51
4149577-14957711.97811.98
5161906-16190612.96512.97
6152491-15249112.21112.21
10min1179106-17910614.34214.201.1514.3614.221.16
2178435-17843514.28914.31
3173777-17377713.91613.93
4177305-17730514.19814.22
5178945-17894514.33014.35
6176373-17637314.12414.14
15min1180482-18048214.45314.390.7314.4914.420.71
2180754-18075414.47414.51
3177937-17793714.24914.29
4179140-17914014.34514.38
5181119-18111914.50414.54
6178593-17859314.30114.34
20min1181948-18194814.57014.440.8214.6314.500.81
2181545-18154514.53814.60
3178818-17881814.31914.38
4179906-17990614.40614.47
5181292-18129214.51714.58
6178540-17854014.29714.36
30min1182108-18210814.58314.470.8914.6714.550.90
2182286-18228614.59714.68
3179614-17961414.38314.46
4179658-17965814.38714.47
5181845-18184514.56214.65
6178552-17855214.29814.38
45min1181703-18170314.55014.460.7214.6614.570.72
2181926-18192614.56814.67
3180487-18048714.45314.56
4179401-17940114.36614.47
5181357-18135714.52314.63
6178799-17879914.31814.42
60min1181936-18193614.56914.450.8514.7014.580.87
2182055-18205514.57914.71
3180016-18001614.41514.54
4179650-17965014.38614.51
5181014-18101414.49514.62
6178059-17805914.25914.38
120min1186889-18688914.96614.890.8015.1215.040.81
2187788-18778815.03815.19
3185600-18560014.86215.01
4184443-18444314.77014.92
5186931-18693114.96915.12
6184117-18411714.74414.89
180min1186386-18638614.92514.830.9415.1015.000.95
2187428-18742815.00915.18
3184955-18495514.81114.98
4183714-18371414.71114.88
5186186-18618614.90915.08
6182862-18286214.64314.81
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1185534-18553414.85714.790.7815.0514.980.76
2186535-18653514.93715.13
3184510-18451014.77514.97
4183389-18338914.68514.88
5185446-18544614.85015.04
6182760-18276014.63514.83
360min1184706-18470614.79114.710.8415.0114.930.83
2185168-18516814.82815.04
3183608-18360814.70314.92
4182458-18245814.61114.82
5185041-18504114.81815.03
6181385-18138514.52514.74
480min1183141-18314114.66614.600.8414.9014.840.84
2183939-18393914.72914.97
3182154-18215414.58714.82
4180929-18092914.48814.72
5183522-18352214.69614.94
6180119-18011914.42414.66
600min1181844-18184414.56214.510.9714.8214.770.97
2183757-18375714.71514.98
3181073-18107314.50014.76
4179599-17959914.38214.64
5182161-18216114.58714.85
6178990-17899014.33314.59
720min1181242-18124214.51314.420.9114.8014.700.92
2181933-18193314.56914.85
3180047-18004714.41814.70
4178546-17854614.29814.58
5181116-18111614.50314.79
6177790-17779014.23714.51
极限1180122-18012214.42414.390.8614.7314.690.86
2181453-18145314.53014.84
3179636-17963614.38514.68
4178143-17814314.26514.57
5181193-18119314.51014.81
6177754-17775414.23414.53
二甲双胍片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.279747709746749737269739889737899741890.06
210.259739439732409735920.06
单位质量响应值RSD%判断
94857.7494984.590.10数据可信
供试品溶液-25041001批-恩格列净-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min162287-622876.5626.592.036.566.592.00
260705-607056.3956.40
364183-641836.7626.76
462306-623066.5646.56
563821-638216.7246.72
662123-621236.5456.54
10min1115528-11552812.17112.081.2512.1812.091.25
2113736-11373611.98211.99
3112571-11257111.85911.87
4116062-11606212.22712.24
5116037-11603712.22512.23
6114046-11404612.01512.02
15min1154432-15443216.27016.141.1416.3016.171.13
2151992-15199216.01216.04
3151525-15152515.96315.99
4155322-15532216.36316.39
5154569-15456916.28416.31
6151491-15149115.96015.99
20min1185815-18581519.57619.391.1919.6319.451.20
2181680-18168019.14019.19
3183676-18367619.35019.40
4186749-18674919.67419.73
5185138-18513819.50419.56
6181481-18148119.11919.17
30min1235074-23507424.76524.691.1024.8524.771.10
2231449-23144924.38324.46
3233814-23381424.63224.71
4237161-23716124.98525.07
5237234-23723424.99325.07
6231599-23159924.39924.48
45min1294354-29435431.01030.980.9431.1331.100.94
2290679-29067930.62330.74
3295369-29536931.11731.24
4297325-29732531.32331.44
5295778-29577831.16031.28
6290768-29076830.63330.75
60min1344473-34447336.29036.171.1036.4636.341.10
2339373-33937335.75335.92
3344145-34414536.25636.42
4347981-34798136.66036.83
5345694-34569436.41936.59
6338269-33826935.63735.80
120min1504994-50499453.20152.980.9253.4253.200.92
2496779-49677952.33652.55
3505399-50539953.24453.46
4506557-50655753.36653.59
5506355-50635553.34553.57
6497289-49728952.39052.61
180min1611958-61195864.47064.190.9064.7764.490.90
2603093-60309363.53663.83
3613364-61336464.61864.92
4611741-61174164.44764.75
5613877-61387764.67264.97
6601652-60165263.38463.68
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1693640-69364073.07572.760.8373.4773.160.83
2682885-68288571.94272.33
3694343-69434373.14973.55
4693467-69346773.05773.46
5695629-69562973.28573.68
6683942-68394272.05472.44
360min1812218-81221885.56884.900.8286.0785.410.82
2797292-79729283.99584.49
3809613-80961385.29385.80
4808095-80809585.13385.64
5810266-81026685.36285.87
6798044-79804484.07484.57
480min1885143-88514393.25092.590.7993.8893.220.79
2868753-86875391.52492.15
3882733-88273392.99693.63
4882198-88219892.94093.58
5882837-88283793.00793.64
6871496-87149691.81392.44
600min1924180-92418097.36396.880.6898.1497.660.68
2911024-91102495.97796.74
3925225-92522597.47398.25
4923560-92356097.29898.07
5921131-92113197.04297.82
6912660-91266096.14996.91
720min1945118-94511899.56998.890.68100.4999.800.68
2929155-92915597.88798.79
3942704-94270499.314100.23
4940756-94075699.109100.03
5941737-94173799.213100.13
6932606-93260698.25199.16
极限1943601-94360199.40998.820.63100.4899.880.63
2928606-92860697.82998.88
3941086-94108699.144100.21
4940983-94098399.133100.20
5940665-94066599.100100.17
6933069-93306998.29999.35
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